Athletic PerformanceNCT05936398
Influence of Respiratory Muscle Training on Objective and Subjective Training Load Measures in Triathletes
A study testing Respiratory Muscle Training - VIH and Respiratory Muscle Training - ITPL in people with Athletic Performance, run by Institute of Sport - National Research Institute, Poland at 1 site in Poland.
Trial summary
Two groups of healthy, highly trained triathletes trained respiratory muscles with one of the two methods: voluntary isocapnic hyperpnoea (VIH) or inspiratory pressure threshold loading (IPTL). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletic Performance
- What is being tested?
- Respiratory Muscle Training - VIH and Respiratory Muscle Training - ITPL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2023to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- valid medical certificate to compete sports professionally,
- lack of ongoing medication intake,
- lack of any medical condition,
- lack of previous experience with RMT,
- lack of previous experience with RMT,
- performance caliber corresponding to at HighlyTrained/Elite (Participant Classification Framework, McKay 2022),
- at least 6 years of triathlon training,
- average training volume over 12 hours per week during last 6 weeks.
Who cannot join
- any ongoing medication intake or medical condition.
Trial locations and contacts
1 site in 1 country.
About this study
Two groups of healthy, highly trained triathletes trained respiratory muscles with one of the two methods: voluntary isocapnic hyperpnoea (VIH) or inspiratory pressure threshold loading (IPTL). The main purpose of this study was to accurately and thoroughly assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods.
Informed written consent was obtained from the all study participants. All procedures were carried out in accordance with the Declaration of Helsinki.
Read the detailed description
The study was conducted as a randomized controlled trial with two parallel groups. Whereas participants and data collectors were aware of the allocated training method, the data analysts and laboratory technicians performing biochemistry assays were kept blinded to the allocation. The participants were assigned at random to either VIH or IPTL training group to perform RMT with progressive overload for 6 weeks.
Three training sessions (week 1, 4, 6) were monitor to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods.
Blood samples used for acid-base balance (pH), partial pressure of oxygen (pO2), partial pressure for carbon dioxide (pCO2), partial pressure for bicarbonate ion (HCO3-), and blood lactate (bLa) were collected immediately after cessation of the exercise and MPQ was presented 1' after cessation of the exercise. Blood samples for cortisol (C) and testosterone (T) were collected 5' after cessation of the exercise. The second S-Index Test was performed between minute 5 and minute 7 after cessation of the exercise. RPE was assessed 10' after cessation of the exercise. The participants again answered MPQ after 24h and 48h after the monitored RMT sessions.
Informed written consent was obtained from the all study participants. All procedures were carried out in accordance with the Declaration of Helsinki.
- Conditions
- Athletic Performance
- Being tested
- Respiratory Muscle Training - VIH, Respiratory Muscle Training - ITPL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Muscle Training - VIHBehavioural
The VIH group will train every second day with gradual progression based on session length and breathing frequency. Participants will begin with 3 minutes of exercise with a frequency of 20 breaths·min-1 during the first session and add no more than 1 minute or 2 breaths·min-1 with each consecutive session.
Respiratory Muscle Training - ITPLBehavioural
The IPTL group will train 5 days a week, twice a day, with at least 6 hours break between sessions. The session will consist of 30 dynamic inspiratory maneuvers with progressive overload based on gradually increased resistance. The VIH group will train every second day with gradual progression based on session length and breathing frequency. Participants will begin with 3 minutes of exercise with a frequency of 20 breaths·min-1 during the first session and add no more than 1 minute or 2 breaths·min-1 with each consecutive session.
| Study group | Role | What they receive |
|---|---|---|
| Voluntary Isocapnic Hyperpnoea (VIH) | Active comparator | Group performing respiratory muscle training with Voluntary Isocapnic Hyperpnoea (VIH) method. Receives: Behavioral: Respiratory Muscle Training - VIH |
| Inspiratory Pressure Threshold Loading (IPTL) | Active comparator | Group performing respiratory muscle training with Inspiratory Pressure Threshold Loading (IPTL) method. Receives: Behavioral: Respiratory Muscle Training - ITPL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (pH)
Differences in pre- and post- RMT session in pH.
Measured: Week 1, 4 and 6 after monitored RMT sessions.
Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (pO2).
Differences in pre- and post- RMT session in pO2.
Measured: Week 1, 4 and 6 after monitored RMT sessions.
Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (pCO2).
Differences in pre- and post- RMT session in pCO2.
Measured: Week 1, 4 and 6 after monitored RMT sessions.
Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (CHO3).
Differences in pre- and post- RMT session in CHO3. CHO3.
Measured: Week 1, 4 and 6 after monitored RMT sessions.
Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (lactate).
Differences in pre- and post- RMT session in blood lactate levels.
Measured: Week 1, 4 and 6 after monitored RMT sessions.
Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (testosterone).
Differences in pre- and post- RMT session in testosterone.
Measured: Week 1, 4 and 6 after monitored RMT sessions.
Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (cortisol).
Differences in pre- and post- RMT session in cortisol.
Measured: Week 1, 4 and 6 after monitored RMT sessions.
Changes in cardiac indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods.
Differences in HR indices between methods, increase of HR and decrease of HR after the cessation on the exercise.
Measured: Week 1, 4 and 6 after monitored RMT sessions.
Collecting subjective measures to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (RPE)
Collecting perceived exertion numbers (Rate of Perceived Exertion - RPE)
Measured: Week 1, 4 and 6 after monitored RMT sessions.
Collecting subjective measures to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (MPQ).
Collecting McGill Pain Questionnaire immediately post-session (MPQ scale).
Measured: Week 1, 4 and 6 after monitored RMT sessions.
Collecting local blood oxygenation during RMT to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods.
Measuring SMO2 before, during and after RMT sessions to assess induced changes.
Measured: Week 1, 4 and 6 after monitored RMT sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Mar 2023
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Sport - National Research Institute, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Kowalski, Institute of Sport - National Research Institute, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936398
- Sponsor's protocol ID
- TK02/2023
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Respiratory Muscle Training on Objective and Subjective Training Load Measures in Triathletes
- ClinicalTrials.gov ID
- NCT05936398
- Acronym / sponsor ID
- TK02/2023
- Conditions
- Athletic Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Institute of Sport - National Research Institute, PolandUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two groups of healthy, highly trained triathletes trained respiratory muscles with one of the two methods: voluntary isocapnic hyperpnoea (VIH) or inspiratory pressure threshold loading (IPTL). The main purpose of this study was to accurately and thoroughly assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods.
Informed written consent was obtained from the all study participants. All procedures were carried out in accordance with the Declaration of Helsinki.
Detailed description
The study was conducted as a randomized controlled trial with two parallel groups. Whereas participants and data collectors were aware of the allocated training method, the data analysts and laboratory technicians performing biochemistry assays were kept blinded to the allocation. The participants were assigned at random to either VIH or IPTL training group to perform RMT with progressive overload for 6 weeks.
Three training sessions (week 1, 4, 6) were monitor to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods.
Blood samples used for acid-base balance (pH), partial pressure of oxygen (pO2), partial pressure for carbon dioxide (pCO2), partial pressure for bicarbonate ion (HCO3-), and blood lactate (bLa) were collected immediately after cessation of the exercise and MPQ was presented 1' after cessation of the exercise. Blood samples for cortisol (C) and testosterone (T) were collected 5' after cessation of the exercise. The second S-Index Test was performed between minute 5 and minute 7 after cessation of the exercise. RPE was assessed 10' after cessation of the exercise. The participants again answered MPQ after 24h and 48h after the monitored RMT sessions.
Informed written consent was obtained from the all study participants. All procedures were carried out in accordance with the Declaration of Helsinki.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voluntary Isocapnic Hyperpnoea (VIH) | Active comparator | Behavioral: Respiratory Muscle Training - VIHGroup performing respiratory muscle training with Voluntary Isocapnic Hyperpnoea (VIH) method. |
| Inspiratory Pressure Threshold Loading (IPTL) | Active comparator | Behavioral: Respiratory Muscle Training - ITPLGroup performing respiratory muscle training with Inspiratory Pressure Threshold Loading (IPTL) method. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- valid medical certificate to compete sports professionally,
- lack of ongoing medication intake,
- lack of any medical condition,
- lack of previous experience with RMT,
- lack of previous experience with RMT,
Key exclusion criteria (1 listed)
- any ongoing medication intake or medical condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory Muscle Training - VIHThe VIH group will train every second day with gradual progression based on session length and breathing frequency. Participants will begin with 3 minutes of exercise with a frequency of 20 breaths·min-1 during the first session and add no more than 1 minute or 2 breaths·min-1 with each consecutive session. | Behavioural | Voluntary Isocapnic Hyperpnoea (VIH) |
| Respiratory Muscle Training - ITPLThe IPTL group will train 5 days a week, twice a day, with at least 6 hours break between sessions. The session will consist of 30 dynamic inspiratory maneuvers with progressive overload based on gradually increased resistance. The VIH group will train every second day with gradual progression based on session length and breathing frequency. Participants will begin with 3 minutes of exercise with a frequency of 20 breaths·min-1 during the first session and add no more than 1 minute or 2 breaths·min-1 with each consecutive session. | Behavioural | Inspiratory Pressure Threshold Loading (IPTL) |
Primary outcome
Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (pH)
Time frame: Week 1, 4 and 6 after monitored RMT sessions.
Differences in pre- and post- RMT session in pH.
Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (pO2).
Time frame: Week 1, 4 and 6 after monitored RMT sessions.
Differences in pre- and post- RMT session in pO2.
Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (pCO2).
Time frame: Week 1, 4 and 6 after monitored RMT sessions.
Differences in pre- and post- RMT session in pCO2.
Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (CHO3).
Time frame: Week 1, 4 and 6 after monitored RMT sessions.
Differences in pre- and post- RMT session in CHO3. CHO3.
Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (lactate).
Time frame: Week 1, 4 and 6 after monitored RMT sessions.
Differences in pre- and post- RMT session in blood lactate levels.
Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (testosterone).
Time frame: Week 1, 4 and 6 after monitored RMT sessions.
Differences in pre- and post- RMT session in testosterone.
Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (cortisol).
Time frame: Week 1, 4 and 6 after monitored RMT sessions.
Differences in pre- and post- RMT session in cortisol.
Changes in cardiac indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods.
Time frame: Week 1, 4 and 6 after monitored RMT sessions.
Differences in HR indices between methods, increase of HR and decrease of HR after the cessation on the exercise.
Collecting subjective measures to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (RPE)
Time frame: Week 1, 4 and 6 after monitored RMT sessions.
Collecting perceived exertion numbers (Rate of Perceived Exertion - RPE)
Collecting subjective measures to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (MPQ).
Time frame: Week 1, 4 and 6 after monitored RMT sessions.
Collecting McGill Pain Questionnaire immediately post-session (MPQ scale).
Collecting local blood oxygenation during RMT to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods.
Time frame: Week 1, 4 and 6 after monitored RMT sessions.
Measuring SMO2 before, during and after RMT sessions to assess induced changes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Muscle Training - VIH and Respiratory Muscle Training - ITPL in people with Athletic Performance, run by Institute of Sport - National Research Institute, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (pH) (time frame: Week 1, 4 and 6 after monitored RMT sessions.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.